The effects of a smoking cessation intervention on 14.5-year mortality: a randomized clinical trial

Ann Intern Med. 2005 Feb 15;142(4):233-9. doi: 10.7326/0003-4819-142-4-200502150-00005.


Background: Randomized clinical trials have not yet demonstrated the mortality benefit of smoking cessation.

Objective: To assess the long-term effect on mortality of a randomly applied smoking cessation program.

Design: The Lung Health Study was a randomized clinical trial of smoking cessation. Special intervention participants received the smoking intervention program and were compared with usual care participants. Vital status was followed up to 14.5 years.

Setting: 10 clinical centers in the United States and Canada.

Patients: 5887 middle-aged volunteers with asymptomatic airway obstruction.

Measurements: All-cause mortality and mortality due to cardiovascular disease, lung cancer, and other respiratory disease.

Intervention: The intervention was a 10-week smoking cessation program that included a strong physician message and 12 group sessions using behavior modification and nicotine gum, plus either ipratropium or a placebo inhaler.

Results: At 5 years, 21.7% of special intervention participants had stopped smoking since study entry compared with 5.4% of usual care participants. After up to 14.5 years of follow-up, 731 patients died: 33% of lung cancer, 22% of cardiovascular disease, 7.8% of respiratory disease other than cancer, and 2.3% of unknown causes. All-cause mortality was significantly lower in the special intervention group than in the usual care group (8.83 per 1000 person-years vs. 10.38 per 1000 person-years; P = 0.03). The hazard ratio for mortality in the usual care group compared with the special intervention group was 1.18 (95% CI, 1.02 to 1.37). Differences in death rates for both lung cancer and cardiovascular disease were greater when death rates were analyzed by smoking habit.

Limitations: Results apply only to individuals with airway obstruction.

Conclusion: Smoking cessation intervention programs can have a substantial effect on subsequent mortality, even when successful in a minority of participants.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Behavior Therapy
  • Bronchodilator Agents / therapeutic use
  • Cause of Death
  • Female
  • Follow-Up Studies
  • Forced Expiratory Volume / drug effects
  • Humans
  • Ipratropium / therapeutic use
  • Male
  • Mortality*
  • Pulmonary Disease, Chronic Obstructive / drug therapy
  • Pulmonary Disease, Chronic Obstructive / etiology
  • Pulmonary Disease, Chronic Obstructive / therapy*
  • Smoking / adverse effects
  • Smoking / physiopathology
  • Smoking Cessation / methods*
  • Smoking Prevention


  • Bronchodilator Agents
  • Ipratropium